Vessel closure device

ABSTRACT

The present invention relates to closing an opening within a subcutaneous bodily vessel by using a spiral closure device to engage tissue around the opening. The spiral closure device is adapted to be threaded into the vessel wall surrounding the opening in the bodily vessel. A deployment mechanism may be used to rotate the spiral closure device. As the deployment mechanism is rotated the spiral closure device is rotated such that a tip of the spiral closure device engages the vessel wall around the opening in the bodily vessel. Continued rotation of the spiral closure device threads the closure device through the tissue around the opening. The closure device may have a tapered configuration in which the distal end is larger than the proximal end. As the distal end is threaded through the vessel wall, the narrowing closure device pulls the vessel wall tissue together, thereby effectively closing the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 11/427,309,now U.S. Pat. No. 8,556,930, filed 28 Jun. 2006, the disclosure of whichis incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

Exemplary embodiments of the present invention generally relate toapparatus, systems and methods for closing an opening in a body vesselof a human or animal. More particularly, embodiments of the presentinvention generally relate to devices for engaging tissue around anopening in a body vessel formed during a percutaneous medical procedure,and to systems and methods for using such devices.

2. The Relevant Technology

One element in any medical procedure is the control and stoppage ofblood loss. Stopping blood loss is a particular concern in intravascularmedical procedures where a laceration in a vein or artery is made togrant venous or arterial access. Such procedures may be diagnostic ortherapeutic in nature, and commonly involve, for example, the insertion,use, and removal of a catheter or stent to diagnose or treat a medicalcondition. During the procedure, an introducer sheath may allowintroduction of various devices into the vessel while also minimizingblood loss during the procedure. Upon completion of the procedure,however, the devices and the introducer may be removed, thereby leavinga laceration or puncture in the vessel wall.

This laceration or puncture site is of particular concern in controllingthe patient's blood loss. If the site is left unsealed, blood may escapeand enter into the surrounding body cavities and tissue. Where excessiveblood escapes, the effectiveness of the medical procedure may becompromised and complications may arise. To avoid or counter thesecomplications, the medical staff must be vigilant in providing continuedcare to the patient following an intravascular procedure.

One method used to avoid excessive bleeding is to apply pressure to theaffected area. This process attempts to block flow from the body vesseluntil the natural clotting process is complete. Pressure may be manuallyapplied, or with a sandbag, bandage, or clamp. Moreover, theeffectiveness of this pressure is compromised unless the patient remainsnearly motionless while the pressure is applied. Patients are monitoredduring the time during which clotting is occurring, thereby alsorequiring much of a physician's or nurse's time. Typically, this naturalprocess takes up to two hours; however, with other patients even moretime may be required. The need for the patient to be immobilized cancause discomfort to the patient. In addition, the time for hemostasispotentially increases both the time during which the medical staff mustmonitor the patient as well as the patient's hospital stay, thus addingto the expense of the procedure.

Additional devices and techniques have been suggested to reduce theamount of time for hemostasis by percutaneously sealing a vascularopening by plugging, suturing and/or mechanically closing the puncturesite. For example, collagen plugs are well known in the art. Thecollagen plug may be deployed into the vascular opening through anintroducer sheath. When deployed, the blood or other body fluids causethe collagen plug to swell, such that it blocks the access site andprovides hemostasis. Such devices may, however, be difficult to properlyposition in the vessel. Consequently, an improperly deployed plug mayblock the flow of fluid in the vessel, and/or be released into the bloodstream where it can float downstream and potentially embolize.

Other mechanical devices or methods have been suggested for closing apuncture site. By way of example, a staple may be used. In oneconfiguration, an “S” shaped staple includes barbs that may engagetissue on either side of the wound. Another staple may be ring-shapedand include barbs that project from the ring. Sides of the ring can besqueezed to separate the barbs, while the barbs may engage the tissue oneither side of the wound. The sides can then be released, causing thebarbs to return closer together, thereby also pulling the tissue closedover the wound. These staples, however, have a large cross-sectionalprofile and may not be easy to deliver through a percutaneous accesssite to close an opening in a vessel wall.

Accordingly, there remains a need for a vascular closure device whichpromotes rapid hemostasis and which can be easily positioned anddeployed into a small access site to close an opening or puncture in abodily vessel.

BRIEF SUMMARY OF THE INVENTION

Exemplary embodiments of the invention relate to a closure device forclosing an access site in a bodily vessel following a percutaneousmedical procedure. The closure device reduces the risk of bleedingfollowing a medical procedure by improving the ability of medicalpersonnel to quickly and easily close an access site of a blood vessel.The use of the closure device accelerates hemostasis in the patient,thus reducing the health risks associated with excess blood loss.Additionally, the vessel closure device allows a patient a near fullrange of motion soon after surgery, thus reducing the expenses of theprocedure and corresponding hospital stay.

In one embodiment of the present invention, a vessel closure deviceincludes a spiral clip. The spiral clip may be adapted to engage thetissue surrounding an opening in a bodily vessel, thereby pulling thetissue together and closing the opening. For example, the spiral clipmay engage the walls of a blood vessel and pull the vessel wallstogether to close the opening. In some embodiments, the spiral clip canbe a wire having a plurality of coils. Optionally, the spiral clip canbe tapered such that one end of the clip can be wider than a second endof the clip. In another alternative, the medial portion of the clip maybe wider than either end of the clip.

The spiral clip engages the vessel walls or other tissue when rotated.For example, the spiral clip may be a helically wound wire which, whenrotated, extends into the vessel wall around the vascular opening. Inother embodiments, the spiral clip can be a fastener with spiralthreads, or a helical wire wound around a fastener, and grips the vesselwalls when rotated. The spiral clip may be rotated by a deploymentmechanism. The deployment mechanism may rotate in a first direction tofacilitate engagement of the spiral clip with the tissue, or be rotatedin a second direction to disengage the clip from the deploymentmechanism. Optionally, the clip may be hollow or have an opening thereinfor receiving a vessel locator which can be positioned in the opening,through the clip, to determine the location of the opening in the bodilyvessel so as to properly position the spiral clip.

In another embodiment, a system for closing an opening in a bodilyvessel is described. Such system may include, for example, a spiralclosure device and a deployment mechanism having an opening therein toreceive the spiral closure device. The deployment mechanism can deploythe spiral closure device by rotatably engaging the closure device tothereby close an opening in a bodily vessel. The spiral closure devicemay also be compressible to allow it to be received within thedeployment mechanism. For instance, the closure device may be a taperedhelical wire which has a natural shape that, at least in part, can be ofa size that would not fit within the deployment mechanism but which,when compressed, can be received therein.

The deployment mechanism can, in some embodiments, include a tube inwhich the spiral closure device can be received. Further embodiments mayalso include a plunger within the tube, and such that the plungertraverses the tube along an axis of the tube and rotatably engages thespiral closure device. The deployment mechanism may further be threadedto facilitate movement of the spiral closure device into the vascularopening. For example, a plunger may have external threads on its outersurface, while a tube has mating internal threads on an inner surface,such that as the plunger can be rotated, the plunger moves along an axisof the tube. In other embodiments, the inner surface of the tube hasexternal threads and the outer surface of the plunger has internalthreads. In yet another embodiment, a tube may have internal threads inwhich coils of a helical wire are received and such that as the spiralclosure device can be rotated, it moves along the threads and along anaxis of the tube.

A vessel closure system may also include a vessel locator forpositioning the spiral closure device in the vascular opening. Forexample, a tube or other type of bleed-back device may be used. Forinstance, the bleed-back device can be inserted through the deploymentmechanism and/or the spiral closure device. When the bleed-back devicefinds the vascular opening, it can be inserted into the lumen of thevessel such that blood or other bodily fluids are received in the deviceand flow through the device to exit at the distal end. This provides avisual indication to the medical personnel using the closure device thatthe vessel closure system is positioned for deployment. Upon viewing thefluid, and thereby determining that the locator and deployment mechanismare in place, the spiral closure device can be deployed and the vascularopening closed.

In other embodiments, a method for installing a vessel closure device isdisclosed. The method can include, for example, locating the opening inthe bodily vessel and positioning the deployment mechanism at theopening. Thereafter, and using the deployment mechanism, a spiralclosure device can be deployed into the opening such that the spiralclosure engages and pulls together the vessel wall tissue surroundingthe opening. Locating the opening can further include extending a vessellocator through the deployment mechanism and/or closure device into alumen of a bodily vessel and determining that fluid from the lumen isbeing received through the vessel locator.

The deployment mechanism can include a tube and a deployment membermoving along an axis of the tubular receiving member. As such, using thedeployment mechanism to rotatably deploy the spiral closure device mayinclude removably mounting the spiral closure device to the deploymentmember and rotating the deployment member such that rotating thedeployment member moves it along the axis of the receiving member andcauses the spiral closure device to rotatably engage the vessel walltissue.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope, nor are theynecessarily drawn to scale. The invention will be described andexplained with additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 illustrates a perspective view of a closure device in accordancewith one embodiment of the invention;

FIG. 2A is partial cut-away view illustrating one embodiment of a systemfor closing an opening in a vessel wall using a spiral closure device;

FIG. 2B illustrates a bottom view of a deployment member having aretention sleeve or recess for receiving a spiral closure device;

FIG. 3 illustrates the vessel wall of FIG. 2A after deployment of aspiral closure device to close an opening in the wall, according to oneembodiment of the invention;

FIG. 4 illustrates an alternative embodiment of a vessel closure device;

FIG. 5 illustrates a vessel closure device according to yet anotherembodiment of the present invention; and

FIG. 6 illustrates an exemplary deployment mechanism for use inrotatably deploying a spiral closure device according to one embodimentof the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Exemplary embodiments of the present invention include delivery of aclosure device for closing an opening or other laceration or puncture inthe wall of a bodily vessel, thereby promoting hemostasis. When insertedinto a vessel wall, the vessel closure device improves patient safety bydrawing the vessel wall together, thereby reducing or eliminatingleakage from the blood vessel into the surrounding tissue. The vesselclosure device may be useful for a variety of medical proceduresaccessing blood vessels or other bodily vessels such as, for example,bodily cavities or bodily organs. The use of a closure device accordingto embodiments of the present invention can improve patient safety whilealso being capable of quick and efficient positioning and installation.

Referring now to FIG. 1, an exemplary embodiment of a vessel closuredevice 10 is illustrated. In the illustrated embodiment, vessel closuredevice 10 comprises a wire 12 wound in a helical shape such that it hasa spiral configuration. More specifically, wire 12 is wound such that ithas a plurality of coils 18. In this illustrated embodiment, coils 18are substantially parallel, although it will be appreciated in light ofthis disclosure that this is not necessary and coils 18 can have any ofa variety of configurations. For example, and not by way of limitation,vessel closure device 10 may include a second wire such that adouble-helix is formed, and in which the coils of the second wire areperpendicular to the coils of the first wire. Further, the spacing orpitch between adjacent coils 18 of the wire 12 can be equidistant,different spacing, or combinations of equal or different spacings.

Vessel closure device 10 may also have any number of coils or any of avariety of shapes and configurations. For example, in the illustratedembodiment, wire 12 is wound such that vessel closure device 10 issubstantially conical. More particularly, when viewed from above orbelow, coils 18 of vessel closure device 10 are generally circular inshape, and gradually reduce in size from distal end 16 to proximal end14. In this manner, the diameter of a coil adjacent proximal end 14 isless than the diameter of a coil at distal end 16.

As discussed in more detail hereafter, one feature of a taperedconfiguration on vessel closure device 10 is the ability of vesselclosure device 10 to effectively close an opening in a vessel wall. Inparticular, distal tip 17 can enter the vessel wall and coils 18 canthereafter be threaded around an opening in the vessel. As threadingcontinues, the more narrow coils of vessel closure device 10 engage thevessel wall tissue and pull the wall together, thereby closing theopening.

Although a tapered configuration to vessel closure device 10 isillustrated, it will be understood by those skilled in the art thatother configurations are possible and the illustrative nature of theexemplary embodiment should not be considered limiting to the variousother configurations that are possible. For example, wire 12 may bewound in any number of manners. For instance, wire 12 may be wound suchthat vessel closure device 10 has a generally cylindrical shape, with orwithout a taper, or other configurations having only a portion of thedevice being tapered. Moreover, it is not necessary that the coils havea generally circular shape. For example, coils 18 may wound in any otherregular or irregular geometric shape. By way of representation, theshape of one or more of coils 18 may be generally oval, diamond,trapezoidal, or the like.

Moreover, the cross-sectional shape and configuration of wire 12 is notlimited to any particular design. For example, while wire 12 may have asubstantially circular or elliptical cross-sectional shape, this featureis not limiting. For instance, in other embodiments, wire 12 has othercross-sectional shapes, such as but not limited to, triangular, square,diamond-shaped, and trapezoidal cross-sections.

Now referring to FIG. 2A, a system and method for installing vesselclosure device 10 is illustrated and described in greater detail. Asillustrated, one embodiment of a vessel closure system 5 is located atan opening 52 in a bodily vessel 50, and adapted to close opening 52 toprevent fluid loss from a lumen 54 of vessel 50. In this embodiment,vessel closure system 5 can include a delivery mechanism, including adelivery shaft 30 and a deployment member 40 disposed within deliveryshaft 30, and vessel closure device 10 for closing opening 52.

Vessel closure device 10 may also be disposed within, and received by,delivery shaft 30. In particular, in this exemplary embodiment, deliveryshaft 30 includes a chamber 32 extending from a proximal end 38 toward adistal end 36 of delivery shaft 30. For instance, in one configurationthe chamber 32 runs along the length of delivery shaft 30. Chamber 32 isconfigured, in this embodiment, to receive both delivery shaft 30 andvessel closure device 10. For instance, chamber 32 may have across-sectional shape or configuration generally corresponding to thecross-sectional shape of deployment member 40, and slightly larger thandeployment member 40. Accordingly, deployment member 40 can be easilyinserted into chamber 32.

In other embodiments, however, chamber 32 can have a size about equal toor slightly less than the size of at least a portion of deploymentmember 40. In such embodiments, a seal and/or compression fit can beformed between deployment member 40 and the internal surface 39 ofdelivery shaft 30 which surrounds chamber 32. By forming a compressionfit and/or seal within chamber 32, closure system 5 can act to restrictpassing fluid along the length of delivery shaft 30. For instance, fluidthat collects in the portion of delivery shaft 30 which is adjacentvessel 50 can be prevented from passing through delivery shaft 30 to themedical personnel operating closure system 5.

It will be understood that the mounting or mating of deployment member40 with delivery shaft 30 can occur in various other manners. Forinstance, in another configuration, one or more mechanical seals, suchas but not limited to, O-rings, can be mounted to a portion ofdeployment member 40 and be disposed between deployment member 40 andinternal surface 39 of delivery shaft 30 and prevent fluid passingthrough delivery shaft 30.

In addition to or alternatively to creating a seal between deploymentmember 40 and internal surface 39 of delivery shaft 30, closure system 5can include a seal 37 mounted to proximal end 38 of delivery shaft 30.This seal 37 can be one of a variety of different seals, includingoptionally being self-sealing once it is inserted into proximal end 38of delivery shaft 30. The seal 37, for example, may have an elastomericbody, such as silicone rubber or other material, with at least one slitand/or other collapsible opening formed therein to allow movement ofdeployment member 40. The collapsible openings or other portions of theseal 37 maintain a fluid tight seal with or against deployment member40. Thus, blood or other bodily fluids are prevented from leaking out,and unwanted air is prevented from entering into the body. Examples ofsuch flexible membranes or seals which can be utilized with the presentinvention are shown in U.S. Pat. Nos. 4,798,594, 5,176,652, and5,453,095 the entireties of which are herein incorporated by reference.

In the illustrated embodiment, deployment member 40 can be disposedwithin chamber 32 and can be further configured to mount vessel closuredevice 10 to vessel 50 and thereby close opening 52. For example, inthis embodiment, deployment member 40 can include a first, mountingportion 46 and a second, rotation portion 44. Mounting portion 46 has,in this embodiment, a generally circular cross-section and a diameterabout equal to the diameter of the cross-section of chamber 32, and isfurther disposed within channel 32. In contrast, rotation portion 44 hasa diameter less than the diameter of mounting portion 46.

Mounting portion 46 is, in this embodiment, adapted to engage vesselclosure device 10, such that it can be secured within channel 32. Forinstance, mounting portion 46 may include a retention sleeve or recess42 through which a proximal tip 15 (FIG. 1) of proximal end 14 can beinserted. Retention sleeve or recess 42, which is shown in more detailin FIG. 2B and without vessel closure device 10, can retain proximal end14 in any suitable manner. For instance, sleeve or recess 42 can includea curved channel 48 having a shape generally corresponding to thehelical shape of proximal end 14 of vessel closure device 10.Accordingly, curved channel 48 can be ramped or inclined along itslength such that it approximates the shape contour of vessel closuredevice 10 at proximal end 14. In other embodiments, curved channel 48may not be ramped along its length. For instance, all or a portion ofthe length of curved channel 48 may be substantially horizontal. In thismanner, as proximal end 14 of vessel closure device 10 is inserted intocurved channel 48, proximal end 14 is compressed and frictionallyretained within retention sleeve or recess 42.

In light of the disclosure herein, it should be appreciated that anynumber of other mechanisms or retention devices may be used to engagevessel closure device 10 or otherwise secure vessel closure device 10within channel 32. For instance, mounting portion 46 may be temporarilyor permanently charged such that a magnetic field is created. Vesselclosure device 10 may further be made of a ferrous material, or includea ferrous material portion or a coating of ferrous material, andattracted to mounting portion 46 by the magnetic field or be chargedwith an opposite charge. In other embodiments, mounting portion 46 mayinclude a clasp for receiving proximal end 14. It will also beunderstood that combinations of the above are also possible.

Rotation portion 44 can be connected to mounting portion 46. Rotationportion 44 may, for example, be integrally formed with mounting portion46 or otherwise directly or indirectly connected thereto. In someembodiments, rotation portion 44 can be configured to be rotated by themedical personnel using closure system 5 to position vessel closuredevice 10. By rotating rotation portion 44, such as grasping a portionof a proximal portion of the rotation portion 44, the medical personnelalso rotates mounting portion 44 as well as vessel closure device 10.

Rotational motion of rotating vessel closure device 10 causes distal end16 of vessel closure device 10 to engage the vessel wall tissue 51surrounding opening 52. Moreover, by rotating deployment member 30, themedical personnel can cause deployment member 30 to move along the axisof chamber 32 in a direction toward vessel 50. Correspondingly, rotationof deployment member 30 causes vessel closure device 10 to rotate andmove along the axis of chamber 32. In this manner, and as discussed inmore detail hereafter, as rotation portion 44 is rotated, vessel closuredevice 10 is threaded into vessel wall 51 around opening 52. Thus,deployment member 40 can act as a plunger or piston within deliveryshaft 30 by rotatably pushing vessel closure device 10 into opening 52.

Although FIG. 2A illustrates mounting portion 46 and rotation portion 44as having differing sizes, in light of the disclosure herein it shouldbe appreciated that this feature is not limiting. For instance, mountingportion 46 and rotation portion 44 may be integrally formed as a shaftin which each portion has the same cross-sectional shape and the samesize. It should be noted that the mounting portion 46 can have aconfiguration similar to the interior diameter or configuration of thechamber 32 or a configuration enables slidable and/or rotatablecooperation between the mounting portion 46 and the chamber 32.

With continued reference to FIG. 2A, it will be seen that to deployvessel closure device 10 and thereby close opening 52, vessel closuredevice 10 may, in some embodiments, be flexible. This feature may bedesirable for a number of reasons. For example, the width or diameter ofchannel 32 may be less than the width or diameter of one or more coilsof vessel closure device 10. In such a case, a flexible vessel closuredevice 10 allows the larger width portion or portions of vessel closuredevice 10 to be deformed so as to fit within channel 32.

In one embodiment, for example, vessel closure device 10, when in anatural state, is tapered such that a width at the distal end of thedevice is larger than the width at the proximal end. Where the width atthe distal end is larger than channel 32, the distal end may be bent orotherwise deformed to fit within channel 32. Such deformation may, forexample, compress the coils by reducing the width of one or more coils.In some embodiments, to reduce the width of the coils may furtherincrease the length of vessel closure device 10.

Once vessel closure device 10 is positioned within channel 32, whetheror not such positioning requires deformation of vessel closure device10, deployment member 40 can engage vessel closure device 10 and/or bemounted thereto to deploy vessel closure device 10 into opening 52 invessel walls 51. Such deployment of vessel closure device 10 intoopening 52 may be caused in any suitable manner, including thosedescribed herein. For example, rotating deployment mechanism 40 to movedeployment mechanism 40 along the interior of delivery shaft 30 rotatesvessel closure device 10 into vessel walls 51. As deployment mechanism40 rotates and translates, it rotates vessel closure device 10 andpushes it toward distal end 34 of delivery shaft 30. At distal end 34,distal tip 17 of vessel closure device 10 exits delivery shaft 30 and ispressed against vessel walls 51.

When distal tip 17 is pushed against vessel walls 51, it can enter intovessel walls 51 adjacent opening 52. Distal tip 17 can have any suitableconfiguration. For instance, distal tip 17 can be flat or blunt,rounded, or can have a sharpened tip or sharpened edges that extend to asharpened tip, or can have any combination thereof. As should beappreciated in light of the disclosure herein, a sharpened distal tip 17can facilitate entry of vessel closure device 10 into vessel 50.However, this feature is not limiting as the forces applied to vesselclosure device 10 to cause its rotational and/or translational motioncan also be sufficient to cause a blunt or rounded distal tip 17 toenter and engage vessel wall tissue 51.

As vessel closure device 10 continues to rotate and translate, distaltip 17 rotates around opening 52 and through vessel walls 51, and movesdeeper into vessel walls 51. In effect, this provides a threading actionand vessel closure device 10 can be threaded through vessel walls 51surrounding opening 52. Accordingly, as this rotation and translationcontinues, proximal end 14 of vessel closure device 10 is also movedcloser to, and can engage, vessel walls 10.

In some embodiments, such as where vessel closure device 10 is deformedwhen placed in the deployment mechanism comprising delivery shaft 30 anddeployment member 40, vessel closure device 10 may change shape uponexiting distal end 34 of delivery shaft 30. For instance, where thewidth of a coil of the vessel closure device 10 has been compressed, thecoil may return to its natural shape and size upon exiting deliveryshaft 30. Accordingly, and by way of example, where vessel closuredevice 10 has a natural conical or tapered configuration, vessel closuredevice 10 may return to that natural shape when vessel closure device 10is displaced from the deployment mechanism.

A variety of benefits may be obtained by deforming vessel closure device10 to fit within delivery shaft 30 of a deployment mechanism andthereafter allowing vessel closure device 10 to return to its naturalshape. For instance, where the deformation decreases the width or sizeof vessel closure device 10, a smaller delivery shaft 30 may be insertedinto a patient beneath the skin. This allows a smaller incision to beused with the patient, thereby also decreasing the pain, recovery time,and scarring associated with the incision.

In addition, recapture of the natural shape of vessel closure device 10can, in some embodiments, effectively close opening 52 in vessel walls51 and bring portions of surface 56 of vessel walls 51 into together ortowards each other. For instance, with reference now to FIG. 3, anexemplary embodiment of vessel closure device 10 deployed within andclosing opening 52 is illustrated following removal of the deploymentmechanism. In the illustrated embodiment, the height of vessel closuredevice 10 can be about equal to the thickness of the vessel walls 51 andthe width of vessel closure device 10 can be slightly larger than thewidth of the opening in vessel 50. Accordingly, as vessel closure device10 is inserted into the patient, it is secured to the vessel walls 51accessible through opening 52, such as through surface 56, rather thanthe bodily tissue surrounding the vessel. Alternatively, the vesselclosure device 10 can be secured to any portion of the vessel walls 51,whether or not through surface 56.

As will be appreciated in light of the disclosure herein, theillustrated configuration and size of vessel closure device 10 is notnecessarily a limiting feature of the present invention. In particular,the size of vessel closure device 10 can be varied in any suitablemanner as necessary for a particular application. For instance, vesselclosure device 10 can be produced in any of various sizes suitable for apatient, medical procedure and/or body lumen which is being accessed.

As illustrated, vessel closure device 10 has a natural shape that isgenerally conical or tapered. The wider, distal end of vessel closuredevice 10 was first threaded into vessel walls 51 and vessel closuredevice 10 was thereafter threaded deeper into vessel walls 51. As vesselclosure device 10 was threaded deeper into vessel walls 51, and thewidth of vessel closure device 10 becomes increasingly narrow, vesselclosure device 10 continues to engage vessel wall tissue 51. As vesselclosure device 10 narrows, it naturally pulls the tissue surroundingopening 52 together, thereby closing opening 52 or at least reducing thesize of opening 52 to restrict the amount of fluid that can flow throughopening 52.

To obtain these and other characteristics, in one embodiment, a closuredevice can be comprised of biocompatible materials that are at leasttemporarily deformable. Suitable biocompatible materials include, forexample, superelastic materials (e.g., Nitinol). In addition, and by wayof representation only, other suitable materials may include stainlesssteel, silver, platinum, tantalum, palladium, cobalt-chromium alloys,niobium, iridium, any equivalents thereof, alloys thereof orcombinations thereof.

In addition, embodiments of a closure device may comprise a shape memorymaterial. For example, the shape memory material can be shaped in amanner that allows deformation and restriction to induce a substantiallytubular, linear orientation while within a delivery shaft, but canautomatically retain the memory shape of the vessel closure device onceextended from the delivery shaft. Shape memory materials have a shapememory effect in which they can be made to remember a particular shape.Once a shape has been remembered, the shape memory material may be bentout of shape or deformed and then returned to its original shape byunloading from strain or by heating. Typically, shape memory materialscan be shape memory alloys (“SMA”) comprised of metal alloys, or shapememory plastics (“SMP”) comprised of polymers or shape memory metals(“SMM”).

Usually, an SMA can have any non-characteristic initial shape that canthen be configured into a memory shape by heating the SMA and confirmingthe SMA into the desired memory shape. After the SMA is cooled, thedesired memory shape can be retained. This allows for the SMA to bebent, straightened, compacted, and placed into various contortions bythe application of requisite forces; however, after the forces arereleased the SMA can be capable of returning to the memory or naturalshape. The main types of SMAs include: copper-zinc-aluminum;copper-aluminum-nickel; nickel-titanium (“NiTi”) alloys known asNitinol; and cobalt-chromium-nickel alloys orcobalt-chromium-nickel-molybdenum alloys known as Elgiloy. However,other types of SMAs can be used. Typically, the nitinol and Elgiloyalloys can be more expensive, but have superior mechanicalcharacteristics in comparison with the copper-based SMAs. Thetemperatures at which the SMA changes its crystallographic structure arecharacteristic of the alloy, and can be tuned by varying the elementalratios.

For example, it is contemplated that the wire or one or more othermaterials forming a vessel closure device be comprised of a Ni-TI alloythat forms superelastic Nitinol. In the present case, Nitinol materialscan be trained to remember a certain shape (e.g., a tapered ornon-tapered helical coil). Thereafter, the materials can be deformed inthe delivery shaft, an introducer, dilator, or some other tube, and thenbe released to return to its trained shape. Also, additional materialscan be added to the Nitinol depending on the characteristics desired.

An SMP is a shape-shifting plastic that can be fashioned into a vesselclosure device in accordance with the present invention. When an SMPencounters a temperature above the lowest melting point of theindividual polymers, the blend can make a transition to a rubbery state.The elastic modulus can change more than two orders of magnitude acrossthe transition temperature. As such, an SMP can be formed into a desiredshape of a closure device by heating it above the transitiontemperature, fixing the SMP into the new shape, and cooling the materialbelow the transition temperature. The SMP can then be arranged into atemporary shape by force, and then resume the memory shape once theforce has been applied. Examples of SMPs include biodegradable polymers,such as oligo(ϵ-caprolactone)diol, oligo(ρ-dioxanone)diol, andnon-biodegradable polymers such as, polynorborene, polyisoprene, styrenebutadiene, polyurethane-based materials, vinyl acetate-polyester-basedcompounds, and others yet to be determined. As such, any SMP can be usedin accordance with the present invention.

For example, Veriflex.™., the trade name for CRG's family of shapememory polymer resin systems, currently functions on thermal activationwhich can be customizable from −20.degree. F. to 520.degree. F., whichallows for customization within the normal body temperature. This allowsa vessel closure device comprised of Veriflex.™. to be inserted into adelivery shaft. Once unrestrained by the delivery shaft, the bodytemperature can cause the vessel closure device to spontaneously takeits functional shape.

A vessel closure device made of a SMA, SMP, SMM or suitable superelasticmaterial can be compressed or restrained in its delivery configurationon a delivery device using a sheath, delivery shaft, or similarrestraint, and then deployed to its deployed configuration at a desiredlocation by removal of closure device from the shaft. A vessel closuredevice made of a thermally sensitive material can be deployed byexposure of the closure device to a sufficient temperature to facilitateexpansion.

In still other embodiments, the closure device is comprised at leastpartially of absorbent biomaterials. Suitable biomaterials include, forexample, lyophilized or air-dried submucosal tissue or otherextracellular matrix-derived tissue from warm-blooded vertebrate. Suchmaterials have a variety of characteristics, including one or more of:biological remodeling, resistance to infection, and high similarity toautogenous material. Examples of such submucosal or other extracellularmatrix-derived tissue is described in U.S. Pat. Nos. 4,902,508,5,281,422, 5,573,784, 5,573,821, 6,206,931, and 6,790,220, thedisclosures of which are herein expressly incorporated by reference.

A vessel closure device can include, for example, a coating ofbiomaterial around a wire core as described herein. As such a coatingcan have high similarity to autogenous material of the patient, therecan be a reduced risk that the patient will reject the closure device orreceive an infection. Moreover, biological remodeling characteristics ofmatrix-derived biomaterials can further foster regeneration of tissuearound the closure device to close the opening in the bodily vessel andthereby prevent excess blood loss.

Returning now to FIG. 2A, one embodiment of vessel closure system 5includes a vessel locator 70 for properly aligning and positioningvessel closure device 10 in opening 52. In one embodiment, for example,vessel locator 70 is a bleed-back device.

In the illustrated embodiment, vessel locator 70 is extended through thedeployment mechanism, including delivery shaft 30 and deployment member40. For instance, deployment member 30 may include a channeltherethrough in which a bleed-back device or other suitable type ofvessel locator 70 may be placed. Vessel locator 70 then extends throughchannel 32. Moreover, in some embodiments, vessel locator 70 may alsoextend through vessel closure device 10. For instance, in theillustrated embodiment where vessel closure device 10 is a helical coil,a void can be created within vessel closure device 10 through whichvessel locator 70 extends. In light of the disclosure herein, it shouldbe appreciated, however, that other configurations of a vessel closuredevice may allow for a vessel locator to extend therethrough, including,for example, the creation of a channel through an otherwise solid pin orconnector. In still other embodiments, the vessel locator does notextend through the closure device. For instance, the closure device maybe positioned adjacent the vessel locator.

To determine location of opening 52, the medical personnel operatingclosure system 5 can press locator 70 against vessel wall 51.Periodically, the medical personnel may move vessel locator 70 as theytry to find opening 52. When vessel locator 70 is placed directly overopening 52, the medical personnel can extend vessel locator into thelumen 54 of bodily vessel 50. In exemplary embodiments, such as wherevessel locator 70 is a bleed-back device, fluid in lumen 54 will flowinto vessel locator 70, thereby allowing the medical personnel to viewthe bodily fluid and determine that vessel locator 70 has found opening52.

Once vessel locator 70 has indicated that it is within opening 52,thereby also signaling that closure system 5 is properly positioned withrespect to opening 52, vessel locator may, optionally, then be removedfrom lumen 54 and/or the deployment mechanism. Thereafter, vesselclosure device 10 can be deployed into opening 52 in any suitablemanner. For instance, vessel closure device 10 can be threaded intovessel walls 51 around opening 52 to engage wall tissue 51 and pull ittogether to close opening 52, as described herein, or installed in anyother suitable manner.

Upon installation of vessel closure device 10, the deployment mechanism,including delivery shaft 30 and deployment member 40, can be retractedfrom bodily vessel 54 and removed from the incision in the patient.Prior to retraction and removal, however, the deployment mechanism maybe disengaged or otherwise disconnected from vessel closure device 10.For instance, in the illustrated embodiment, deployment member 40includes retention sleeve 42 in which the proximal tip of vessel closuredevice 10 is received. As deployment member 40 rotates in a firstdirection (e.g., counter-clockwise), deployment member 40 maintains itsconnection with vessel closure device 10 and moves within delivery shaft30 towards vessel 50, such that the distal tip of vessel closure device10 enters vessel wall 51.

If, however, deployment member 40 is rotated in a second direction(e.g., clockwise), deployment member 40 may translate along channel 32away from vessel 50, and may detach from vessel closure device 10. Inthis manner, rotating deployment member in a first direction engages andinstalls vessel closure device 10, while rotation in a second directiondetaches vessel closure device 10 from the deployment mechanism.Consequently, retention sleeve 42 is configured to temporarily andremovably mount vessel closure device 10 to deployment member 40.

The rotational direction of deployment member 40 can be changed in anysuitable manner. For example, medical personnel may manually rotatedeployment member 40. In some embodiments, a ratchet mechanism, as isknown in the art, may be used to facilitate the change of directionand/or rotation of deployment member 40. In addition, it should beappreciated, particularly in light of the disclosure herein, that noparticular rotational direction or motion of deployment member 40 islimiting of the present invention. For instance, deployment member 40may be rotated clockwise to install vessel closure device 10 andcounter-clockwise to detach vessel closure device 10 from the deploymentmechanism.

In other embodiments, vessel closure device 10 can be detached withoutrotating deployment member 40. For instance, as discussed herein,exemplary embodiments may include a clasp holding vessel closure device10 to deployment member 40 or a magnetic field for mounting vesselclosure device 10 to deployment member 40. In such embodiments, vesselclosure device 10 may be detached by releasing the clasp or removing amagnetic field (e.g., by applying or removing an electrical charge orcurrent).

Turning now to FIGS. 4 and 5, various alternative embodiments of aspiral vessel closure device are illustrated. In FIG. 4, for example, avessel closure device 110 is illustrated which has a beehiveconfiguration or double tapered configuration. In particular, asillustrated, vessel closure device 110 comprises a wire 112 that ishelically wound into a plurality of coils, wherein the coils take adouble-conical, beehive configuration.

For example, vessel closure device 110 can include a first, proximal end114 and a second distal end 116. Between proximal end 114 and distal end116 is a medial portion 118. In the illustrated embodiment, the width ofthe coils at proximal end 114 and distal end 116 are less than the widthof the coils at medial portion 118. In this manner, the width of vesselclosure device 110 can increase between proximal end 114 and medialportion 118, and decrease between medial portion 118 and distal end 116.

As should be appreciated, particularly in light of the disclosureherein, vessel closure device 110 can be used to close an opening in anybodily vessel. For example, vessel closure device 110 can be deformedand placed inside a deployment mechanism such that in the closure systemillustrated in FIG. 2A. In particular, vessel closure device 110 can beinserted into a delivery shaft and rotatably deployed using engagementof a proximal tip 115 with the deployment mechanism, such that a distaltip 117 of a distal end 116 of vessel closure device 110 is pushed intoa vessel wall. Vessel closure device 110 can then be further rotated andthreaded into the vessel wall, around an opening therein, while theconical configuration allows vessel closure device 110 to pull thevessel wall together to thereby close off the vascular opening.

FIG. 5 illustrates yet another exemplary embodiment of a spiral vesselclosure device. In the illustrated embodiment, a vessel closure device210 can include a central post 212 around which a plurality of threads218 are wound in a spiral manner. Optionally, at a proximal end 214 ofvessel closure device 210, a cap 211 can be affixed to central post 212.Cap 211 can be configured to, for example, be temporarily and removablymounted to a deployment member so as to be rotatably secured into thevessel wall around an opening in a bodily vessel.

Vessel closure device 210 can also be inserted to close the openingusing a deployment mechanism similar to that illustrated in FIG. 2A. Forexample, vessel closure device 210 can be inserted into a delivery shaftwhile a deployment member engages cap 211 through cooperatingstructures, such as but not limited to, pins, tips, channels, hole,etc., and rotates, thereby also rotating vessel closure device 210 andtranslating it along the length of the delivery shaft. Upon exiting theshaft, the plurality of threads 218 engage the vessel wall around avascular opening, thereby securing vessel closure device 210 to thevessel and also pulling the vessel wall together. Moreover, vesselclosure device 210 can further act as a plug to not only pull the vesselwall together, but to also block the flow of fluid from the lumen of thebodily vessel.

In the illustrated embodiment, threads 218 are illustrated as beingtapered. In particular, the threads nearest distal end 216 are longerthan the threads nearest proximal end 214. It will be appreciated thatsuch threads may be formed integrally with post 212, or may beseparately formed. For instance, threads 218 may be formed of a singlewire that is affixed to post 212.

In another embodiment, threads 218 may not be tapered, such that thediameter of each of threads 218 is equal. In still another embodiment,threads 218 may be of equal length while vessel closure device 210 istapered. For instance, post 212 may be tapered while threads 218 havethe same length, thereby providing a spiraling conical configurationhaving threads of the same length.

Turning now to FIG. 6, an alternative embodiment of a deploymentmechanism 320 is illustrated. In this embodiment, deployment mechanism320 includes a delivery shaft 330 and a mating deployment member 340 forengaging a vessel closure device. Delivery shaft 330 may includeinternal threads 332 on the internal surface of the internal channel,while deployment member 340 has corresponding external threads 342 onthe outer surface.

By including mating threads 332 and 342, a user can quickly and easilyrotate deployment member 340 and also move deployment member 340 alongthe axis of delivery shaft 330. In particular, as deployment member 340is rotated in one direction, threads 332, 342 cause deployment member340 to translate and move along the axis of delivery shaft 330 towards abodily vessel and the distal end 334 of delivery shaft 330. Conversely,when deployment member 340 is rotated in an opposing direction, threads332, 342 cause deployment member 330 to translate and move along theaxis of delivery shaft 330 away from distal end 334.

While threads 332 on delivery shaft 330 are illustrated as internalthreads, and threads 342 on deployment member 340 are illustrated asexternal threads, it will be appreciated that this feature is exemplaryonly. In particular, threads of any type are contemplated. For example,in light of the disclosure herein, it should be appreciated thatinternal threads may be formed on the outer surface of the deploymentmember and mating external threads formed on the internal surface ofdelivery shaft 330.

In some embodiments, delivery shaft 330 may also include internalsecondary threads 336 for receiving a closure device. Internal secondarythreads may be used in addition to, or as an alternative to threads 332.In particular, a spiral vessel closure device, such as one having aplurality of threads or coils, can be set within the internal threads onthe internal surface of delivery shaft 330. Thereafter, deploymentmember 330 can engage the closure device and be rotated—with or withoutthreading—to rotate and translate the closure device into a vessel wallaround a vascular opening.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A method for installing a tissue closure device,the method comprising: locating an opening in tissue; positioning aclosure device adjacent the opening, the closure device having aproximal annular cap and a coiled wire extending from adjacent theannular proximal cap, an elongate member extends through a portion ofthe coiled wire, the coiled wire increasing in diameter from theproximal annular cap toward a distal end of the closure device, adiameter of the proximal annular cap being larger than a diameter of thecoiled wire adjacent the proximal annular cap and at least a diameter ofan intermediate portion of the coiled wire; and deploying the proximalannular cap and the coiled wire of the closure device distally into theopening to engage the coiled wire with the tissue surrounding theopening, the coiled wire engages and pulls the tissue surrounding theopening radially inwardly and reduces blood-loss by the patient afterdeployment.
 2. The method as recited in claim 1, further comprisingrotating the closure device into the tissue surrounding the openingfollowing completing a procedure through the opening.
 3. The method asrecited in claim 1, wherein deploying the closure device furthercomprising releasing the closure device from a deployment mechanism. 4.The method of claim 1, wherein locating the opening in the tissuecomprises: extending a locator through the tissue; and determining thatbodily fluid is being received through the locator.
 5. The method ofclaim 4, wherein determining that bodily fluid is being received throughthe locator comprises identifying bodily fluid passing through ableed-back lumen.
 6. The method of claim 1, wherein the coiled wire issolid.
 7. The method of claim 1, wherein the coiled wire has a circularcross-section.
 8. The method of claim 1, wherein the proximal annularcap is affixed to the elongate member.
 9. A method for reducingblood-flow following a medical procedure, the method comprising:locating an opening in a tissue wall through which a medical procedurewas performed; positioning a tissue closure device at the opening, theclosure device including a proximal annular cap and a coiled wire with asharpened distal tip, an elongate member extends through a portion ofthe coiled wire, the coiled wire increasing in diameter from theproximal annular cap toward a distal end of the closure device, adiameter of the proximal annular cap being larger than a diameter of thecoiled wire adjacent the annular cap and at least a diameter of anintermediate portion of the coiled wire; advancing the closure devicedistally into the tissue wall surrounding the opening; and deploying theclosure device to engage the coiled wire with the tissue wall to engageand pull the tissue surrounding the opening radially inwardly, thecombination of the coiled wire and the elongate member reducingblood-loss by the patient after deployment of the closure device in thetissue wall.
 10. The method of claim 9, wherein the coils of the coiledwire are compressible.
 11. The method of claim 9, wherein advancing theclosure device further comprises advancing the tissue wall along alength of the closure device.
 12. The method of claim 9, whereinadvancing the closure device further comprises advancing the closuredevice from a deployment mechanism, the deployment mechanism comprisingan elongate structure with an opening therein for receiving the closuredevice.
 13. The method of claim 12, further comprising rotatablyengaging the closure device with the deployment mechanism to penetratethe tissue wall with a sharpened distal tip.
 14. The method of claim 9,wherein locating the opening comprises advancing a bleed back lumenassociated with a deployment device into the opening in the tissue wall.15. The method of claim 9, advancing the closure device comprises:removably mounting the closure device to a deployment mechanism; androtating a portion of the deployment mechanism to move the closuredevice to engage the tissue wall.
 16. A method for installing a tissueclosure device so as to reduce blood-loss by the patient, the methodcomprising: locating an opening in a tissue wall; positioning adeployment mechanism at the opening, the deployment mechanism supportinga tissue closure device, the closure device having a proximal annularcap and a coiled wire extending from adjacent the annular cap, anelongate member extends through a portion of the coiled wire, the coiledwire increasing in diameter from the proximal annular cap toward adistal end of the closure device, a diameter of the proximal annular caplarger than a diameter of the coiled wire adjacent the proximal annularcap and at least a diameter of an intermediate portion of the coiledwire; and rotating the deployment mechanism to deploy the tissue closuredevice distally into the tissue wall to engage and pull together thetissue wall surrounding the opening and to reduce blood-loss by thepatient by traversing a plunger, disposed within a tube of thedeployment mechanism, along an axis of the tube.
 17. The method of claim16, wherein the coiled wire comprises a helically wound wire having aplurality of coils and rotatably deploying the tissue closure devicecomprises advancing the plurality of coils into the tissue wall along alength of the closure device.
 18. The method of claim 17, wherein thewire comprises a shape memory material.
 19. The method of claim 16,wherein traversing the plunger comprises traversing a threaded portionof the plunger along threaded portion of the deployment mechanism. 20.The method of claim 16, wherein the tissue closure device engages thetissue wall when rotated in a first direction and disengages from thedeployment mechanism when rotated in a second direction.